Phototherapy devices and methods

ABSTRACT

The present disclosure relates to a phototherapy device that can deliver light to tissues to activate photoactive agents that have been applied to the tissues or that are included within a fiber optic tip member of the device which may be coupled to a light source using a sleeve. The present disclosure also relates to methods of phototherapy using the phototherapy device such as anti-bactericidal treatment, anti-fungal treatment, anti-parasitic treatment, anti-viral treatment.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/703,141, filed on Sep. 13, 2017, which is a divisional application ofU.S. application Ser. No. 13/797,277, filed on Mar. 12, 2013, whichclaims the benefit of U.S. Provisional application No. 61/653,288, filedon May 30, 2012 (now expired). The specifications of each of theabove-references applications are hereby incorporated by reference intheir entirety.

BACKGROUND OF THE DISCLOSURE

Phototherapy has recently been recognized as having a wide range ofapplications in both the medical, cosmetic and dental fields for use insurgeries, therapies and examinations. Phototherapy is commonly used asa means of disinfecting target sites. Phototherapeutic techniques havebeen applied to kill bacteria in the oral cavity and for whiteningteeth. Phototherapy is also used to promote wound healing, skinrejuvenation and to treat skin conditions such as acne. These techniquestypically rely on the use of laser light sources. Lasers, however, canbe very dangerous, particularly in clinical settings, and are typicallyexpensive, large, cumbersome and complicated to use. Accordingly, thereis a need for an improved phototherapy device.

SUMMARY OF THE DISCLOSURE

The present disclosure provides devices and methods useful inphototherapy including phototherapy device members and phototherapy kitsthat can utilize any light source, not necessarily lasers, but stillprovide effective treatment. The use of common clinical light sourcessuch as LEDs or halogen bulbs may be more desirable for phototherapythan lasers due to the cost and other disadvantages associated withlasers. Thereby the phototherapy devices, device members, kits andmethods of the present disclosure may simplify, complement and/orimprove phototherapy regimens, such as for periodontal treatment, woundhealing, collagen modulation, anti-bactericidal treatment, anti-fungaltreatment, anti-parasitic treatment, anti-viral treatment, oranti-inflammatory treatment.

In certain embodiments, the present disclosure relates to a phototherapydevice that can deliver light to the periodontal regions of the mouth toactivate photoactive reagents that have been applied in periodontalpockets, e.g. between the gum and the tooth. The phototherapy device maycomprise a fiber optic tip suitable for delivering light from a lightsource, such as a light emitting diode (LED), to periodontal regions ofthe mouth. The tip may be coupled to the light source using a sleevethat may help to maintain optical alignment. The present disclosure alsorelates to methods of treating and preventing periodontal disease usingthe phototherapy device to kill bacteria in a periodontal treatmentregion.

For purposes of clarity, and not by way of limitation, the devices, kitsand methods of the present disclosure are described herein in thecontext of providing phototherapy for treatment or prevention ofperiodontal disease. However, it will be appreciated that the principlesdescribed herein may be adapted to a wide range of applications, such asfor example in post extractive sockets, endodontic treatment in dentalroot canals, teeth whitening treatment, wound healing, key holesurgery/treatment or any antimicrobial or therapeutic application inhard to reach places of the body where a fiber optic may be useful.

Uses for devices, methods and kits of the present disclosure alsoinclude for collagen modulation, anti-bactericidal treatment,anti-fungal treatment, anti-parasitic treatment, anti-viral treatment,or anti-inflammatory treatment. For example, the principles of thisdisclosure may be applied to phototherapeutic antibacterial treatment ortooth whitening between teeth. In addition, the principles may beapplied to phototherapeutics in connection with orthodontics. Moregenerally, the devices and methods described herein may be employed inany phototherapeutic treatment that requires the application of focusedlight, and in some cases, the application of light in generally closedand hard to reach sites of the mouth or other parts of the body.Accordingly, the devices, kits and methods disclosed herein may beperformed instead of or in addition to conventional treatment methods,including subgingival debridement, supergingival debridement,scaling/root planning, wound healing, skin disorder treatment, topicaland systemic treatments.

One aspect of the present disclosure provides a phototherapeutic devicemember. In some embodiments, the phototherapeutic device membercomprises a flexible fiber optic tip member and an elastic tubularconnector sleeve for mechanically coupling the flexible tip member to alight source. The flexible fiber optic tip member functions as awaveguide and transmits light along its length. The flexible fiber optictip member may have a polymer core for transmitting light. The flexiblefiber optic tip member may be made of any suitable material which cantransmit light and has appropriate optical properties, such as a glass.The flexible fiber optic tip member can include a proximal end and adistal end, wherein the diameter of the proximal end is greater than thediameter of the distal end, and wherein the proximal end is curved tocause light entering the flexible tip member through the proximal end toconverge. The elastic tubular connecting sleeve may include a proximalend having an opening and a distal end having an opening, the proximalend configured to be stretched and mechanically coupled to the lightsource. In use, the flexible fiber optic tip may be partially disposedwithin the elastic tubular connecting sleeve such that the distal end ofthe flexible fiber optic tip member extends distally through the openingin the distal end of the sleeve, and the proximal end of the flexiblefiber optic tip member is disposed within the sleeve and between theproximal and distal ends of the sleeve, thereby positioning the flexiblefiber optic tip member near the light source. The sleeve is configuredto receive the flexible fiber optic tip such that the distal end of theflexible fiber optic tip member extends distally through the opening inthe distal end of the sleeve, and the proximal end of the flexible fiberoptic tip member is disposed within the sleeve and between the proximaland distal ends of the sleeve, thereby positioning the flexible fiberoptic tip member near the light source.

The flexible fiber optic tip may be unitarily formed. The flexible fiberoptic tip may be formed by moulding. Optionally, the flexible fiberoptic tip is cut from a single block of polymer material. In someembodiments, the flexible fiber optic tip member has a rough surfaceformed such as by grating. The flexible fiber optic tip member mayinclude a rough outer surface configured to allow a portion of lighttransmitted through the core to diffuse out through the outer surface.The flexible fiber optic tip can include an optical axis extendingthrough the center of the polymer core from the proximal end to thedistal end, and wherein light passing through the tip member travelsalong at least a portion of the optical axis. The polymer core of theflexible fiber optic tip may comprise polycarbonate orpolymethymethacrylate. The flexible fiber optic tip may further comprisea photoactive agent which can absorb and emit light.

In some embodiments, an interior surface of the elastic tubularconnector sleeve includes a plurality of ribs extending radially inwards(circumferentially) and configured to grip the light source or acatheter. The elastic tubular connector sleeve can be stretched aroundthe light source or catheter and held in place by the ribs. In certainembodiments, the flexible fiber optic tip member is removable from theelastic tubular connector sleeve.

In some embodiments, a proximal region of the flexible fiber optic tipmember is substantially conical having a base along the proximal end.The proximal end of the flexible fiber optic tip member may be convexshaped relative to the proximal portion of the flexible fiber optic tipmember. A distal region of the tip member may be substantiallycylindrical. The length from the proximal end to a distal end of theflexible fiber optic tip member is between about 10 mm and about 30 mm.The length may be much longer than this if a catheter is used. In whichcase the length of the flexible fiber optic tip member will be as longas the length of the catheter. The diameter at the distal end of theflexible fiber optic tip member is optionally between about 500 micronand about 1500 micron. Further, the diameter can vary along the lengthof the flexible fiber optic tip member. The diameter of the distal endof the flexible fiber optic tip members can vary according to the use.In certain embodiments, the distal end of the flexible fiber optic tipmember may comprise a plurality of bristles, e.g. like brush. This maybe useful in applications where debridement may be useful such ascleaning teeth, cleaning wounds, cleaning skin and the like.

In some embodiments, the light source to which the flexible fiber optictip is coupled includes one or more light emitting diodes.Alternatively, the light source may include a halogen lamp. In someembodiments, the flexible fiber optic tip may be coupled to an end of acatheter.

A second aspect of the present disclosure, provides a device forphototherapy. In some embodiments, the device comprises a light source,a probe member having a flexible fiber optic tip member and an elastictubular connector sleeve for mechanically coupling the probe member tothe light source. The proximal end of the flexible fiber optic tipmember may be curved to cause light entering the tip member through theproximal end to converge. The proximal end of the sleeve may beconfigured to be stretched and mechanically coupled to the light source.Optionally, the tip member is partially disposed within the sleeve andextends distally through a distal opening of the sleeve. The device maybe used for treating/preventing periodontitis, in which case a distalend of the flexible fiber optic tip member is sized and/or shaped to bereceived in periodontal pockets. The device may also be used fortreating tissues in hard to reach places, internal tissues and cavitiessuch as through key-hole surgery, in which case the proximal end of thesleeve may be configured to be stretched and mechanically coupled to anend of a catheter. In this case, the flexible fiber optic tip member mayextend along the length of the catheter and be attached to a lightsource at a proximal end of the catheter. A further sleeve according tothe present disclosure may be provided for attaching to the light sourceat the proximal end of the catheter.

The flexible fiber optic tip may be unitarily formed. The flexible fiberoptic tip may be formed by moulding. Optionally, the flexible fiberoptic tip is cut from a single block of polymer material. In someembodiments, the flexible fiber optic tip member is grated to generate arough surface. The flexible fiber optic tip member may include a roughouter surface configured to allow a portion of light transmitted throughthe core to diffuse out through the outer surface. The flexible fiberoptic tip can include an optical axis extending through the center ofthe polymer core from the proximal end to the distal end, and whereinlight passing through the tip member travels along a portion of theoptical axis. The polymer core of the flexible fiber optic tip maycomprise polycarbonate or polymethymethacrylate. The flexible fiberoptic tip may further comprise a photoactive agent which can absorblight and emit as energy.

In some embodiments, an interior surface of the elastic tubularconnector sleeve includes a plurality of ribs extending radially inwards(circumferentially) and configured to grip the light source. In certainembodiments, the flexible fiber optic tip member is removable from thesleeve.

In some embodiments, a proximal region of the flexible fiber optic tipmember is substantially conical having a base along the proximal end. Adistal region of the tip member may be substantially cylindrical. Thelength from the proximal end to a distal end of the flexible fiber optictip member is between about 10 mm and about 30 mm. The length may bemuch longer than this if a catheter is used. In which case the length ofthe flexible fiber optic tip member will be as long as the length of thecatheter. The diameter at the distal end of the flexible fiber optic tipmember is optionally between about 500 micron and about 1500 micron.Further, the diameter can vary along the length of the flexible fiberoptic tip member. The proximal end of the flexible fiber optic tipmember may be convex shaped relative to the proximal portion of theflexible fiber optic tip member. Further, the diameter can vary alongthe length of the flexible fiber optic tip member. The diameter of thedistal end of the flexible fiber optic tip members can vary according tothe use. In certain embodiments, the distal end of the flexible fiberoptic tip member may comprise a plurality of bristles, e.g. like brush.This may be useful in applications where debridement may be useful suchas cleaning teeth, cleaning wounds, cleaning skin and the like.

In some embodiments, the device further comprises an actuating mechanismfor moving at least the flexible fiber optic tip member relative to atreatment surface. For example, the actuating mechanism may furthercomprise a motor in communication with the flexible fiber optic tipmember to move the flexible fiber optic tip member backwards andforwards across the treatment surface (substantially perpendicular tothe optical axis), or to cause the flexible fiber optic tip member tovibrate.

In some embodiments, the light source to which the flexible fiber optictip is coupled includes one or more light emitting diodes.Alternatively, the light source may include a halogen lamp. In someembodiments, the flexible fiber optic tip may be coupled to an end of acatheter.

Another aspect of the present disclosure provides a method =of treatingand/or preventing periodontal disease. In some embodiments, the methodcomprises attaching to a light source having one or more light-emittingdiodes a periodontal probe member, which comprises a flexible fiberoptic tip member with a polymer or glass core for transmitting light,and an elastic tubular connector sleeve, for mechanically coupling theflexible tip member to a light source; introducing a compositioncomprising a photoactivating agent and oxygen-releasing agent into aperiodontal treatment region; introducing the flexible fiber optic tipinto the periodontal treatment region; and applying light through theflexible fiber optic tip member to activate the photoactivating agent inthe periodontal treatment region. By “photoactivating agent” is meant achemical compound which, when contacted by light irradiation, is capableof absorbing the light. The photoactivating agent readily undergoesphotoexcitation and can then transfer its energy to other molecules oremit it as light. The terms “photoactivating agent”, “photoactive agent”and “chromophore” are used herein interchangeably herein.

Another aspect of the present disclosure provides a method for treatingwounds. In some embodiments, the method comprises attaching to a lightsource having one or more light-emitting diodes a probe member, whichcomprises a flexible fiber optic tip member with a polymer or glass corefor transmitting light, and an elastic tubular connector sleeve, formechanically coupling the flexible tip member to a light source or acatheter; introducing a composition comprising a photoactivating agentand oxygen-releasing agent into a treatment region; introducing theflexible fiber optic tip member into the treatment region; and applyinglight through the flexible fiber optic tip member to activate thephotoactivating agent in the treatment region.

Another aspect of the present disclosure provides a method forantibacterial treatment of a tissue site. In some embodiments, themethod comprises attaching to a light source having one or morelight-emitting diodes a probe member, which comprises a flexible fiberoptic tip member with a polymer or glass core for transmitting light,and an elastic tubular connector sleeve, for mechanically coupling theflexible tip member to a light source or a catheter; introducing acomposition comprising a photoactivating agent and an oxygen-releasingagent into a the tissue site; introducing the flexible fiber optic tipmember into the tissue site; and applying light through the flexiblefiber optic tip member to activate the photoactivating agent in thetissue site. The flexible fiber optic tip may be unitarily formed, suchas by moulding. Optionally, the flexible fiber optic tip is cut from asingle block of polymer material. In some embodiments, the flexiblefiber optic tip member is grated to generate a rough surface. Theflexible fiber optic tip member may include a rough outer surfaceconfigured to allow a portion of light transmitted through the core todiffuse out through the outer surface. The flexible fiber optic tip caninclude an optical axis extending through the center of the polymer corefrom the proximal end to the distal end, and wherein light passingthrough the tip member travels along a portion of the optical axis. Thepolymer core of the flexible fiber optic tip may comprise polycarbonateor polymethymethacrylate.

In some embodiments, an interior surface of the elastic tubularconnector sleeve includes a plurality of ribs extending radially inwards(circumferentially) and configured to grip the light source or thecatheter. In certain embodiments, the flexible fiber optic tip member isremovable.

In some embodiments, a proximal region of the flexible fiber optic tipmember is substantially conical having a base along the proximal end.The proximal end of the flexible fiber optic tip member may be convexshaped relative to the proximal portion of the flexible fiber optic tipmember. A distal region of the tip member may be substantiallycylindrical. The length from the proximal end to a distal end of theflexible fiber optic tip member is between about 10 mm and about 30 mm.The length may be much longer than this if a catheter is used. In whichcase the length of the flexible fiber optic tip member will be as longas the length of the catheter. The diameter at the distal end of theflexible fiber optic tip member is optionally between about 500 micronand about 1500 micron. Further, the diameter can vary along the lengthof the flexible fiber optic tip member. The diameter of the distal endof the flexible fiber optic tip members can vary according to the use.In certain embodiments, the distal end of the flexible fiber optic tipmember may comprise a plurality of bristles, e.g. like brush. This maybe useful in applications where debridement may be useful such ascleaning teeth, cleaning wounds, cleaning skin and the like.

The periodontal treatment region can be exposed to the light for aperiod of less than five minutes, such as between one minute and fiveminutes. The method may comprise exposing the periodontal treatmentregion to light for about 1-30 minutes, about 1-25 minutes, about 1-20minutes, about 1-15 minutes, about 1-10 minutes. The method may beperformed over several distinct periodontal treatment regions within theoral cavity. In such cases, each periodontal treatment region exposed tothe light for a period of less than five minutes, such as between oneminute and five minutes. The light may have a wavelength between about400 nm and about 800 nm.

The composition may be introduced on a gingiva within the oral cavity,or a portion thereon. The composition may be introduced near at leastone tooth, preferably on at least one tooth. The composition may beintroduced between a gingiva and a tooth.

The oxygen-releasing agent may be hydrogen peroxide, carbamide peroxideor benzoyl peroxide. The photoactivating agent can be xanthenederivative dye, an azo dye, a biological stain or a carotenoid. Xanthenederivative dyes may be a fluorene dye, a fluorone dye or a rhodole dye.Optionally, the fluorene dye is a pyronine dye, such as pyronine Y orpyronine B, or a rhodamine dye, such as rhodamine B, rhodamine G orrhodamine WT. In some embodiments, the fluorone dye is fluorescein or afluorescein derivative, such as phloxine B, rose Bengal, merbromine,eosin Y, eosin B or erthrosine B, preferably eosin Y. Optionally, theazo dye is methyl violet, neutral red, para red, amaranth, carmoisine,allura red AC, tartrazine, orange G, ponceau 4R, methyl red ormurexide-ammonium purpurate. The biological stain may be saffranin O,basic fuchsin, acid fuchsin, 3,3′ dihexylocarbocyanine iodide, carminicacid or indocyanine green. In some embodiments, the carotenoid iscrocetin, a-crocin, zeaxanthine, lycopene, α-carotene, β-carotene,bixin, fucoxanthine, or a mixture of carotenoid compounds, such assaffron red powder, annatto extract or brown algae extract.

Another aspect of the present disclosure provides a method forphototherapeutic treatment, and which differs from the above method inthat the flexible fiber optic tip member comprises a photoactive agentin the polymer or glass core. In some embodiments, the method comprisesattaching to a light source having one or more light-emitting diodes aprobe member, which comprises a flexible fiber optic tip member with apolymer or glass core for transmitting light and a photoactive agent,and an elastic tubular connector sleeve, for mechanically coupling theflexible tip member to a light source; introducing the flexible fiberoptic tip member into the treatment region; and applying light throughthe flexible fiber optic tip member to activate the photoactive agent.When the photoactive agent is activated by the light, the flexible fiberoptic tip member may fluoresce and or activate oxygen-releasing agentsin the treatment region.

From a yet further aspect, there is provided a kit for phototherapycomprising a plurality of flexible fiber optic tip members, having apolymer or a glass core for transmitting light, the flexible tip memberincluding a proximal end and a distal end, wherein the diameter of theproximal end is greater than the diameter of the distal end, and whereinthe proximal end is curved to cause light entering the flexible tipmember through the proximal end to converge; and an elastic tubularconnector sleeve, for receiving at least a portion of one of theplurality of flexible fiber optic tip members and for mechanicallycoupling the flexible tip member to a light source, wherein the sleeveincludes a proximal end having a first opening and a distal end having asecond opening, the proximal end configured to be stretched andmechanically coupled to the light source.

The plurality of flexible fiber optic tip members may have differentsize and shape distal ends suitable for different applications. Theplurality of flexible fiber optic tip members may include a photoactiveagent in a polymer matrix. In certain embodiments, the kit furthercomprises a biophotonic composition comprising a photoactive agent. Thecomposition may optionally include an oxygen-releasing agent.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a phototherapeutic device, according to an illustrativeembodiment of the present disclosure.

FIG. 2A depicts a flexible fiber optic tip member of the device of FIG.1, according to an illustrative embodiment of the present disclosure.

FIG. 2B-2C depict a flexible fiber optic tip member, of the device ofFIG. 1, having a ridge, according to an illustrative embodiment of thepresent disclosure.

FIG. 2D depicts a flexible fiber optic tip member, of the device of FIG.1, having a rough surface portion, according to an illustrativeembodiment of the present disclosure.

FIG. 3A depicts the coupling of the flexible fiber optic tip member to alight source using an elastic tubular connector sleeve, according to anillustrative embodiment of the present disclosure.

FIG. 3B depicts a zoomed-in view of an elastic tubular connector sleeveof the device of FIG. 1, according to an illustrative embodiment of thepresent disclosure.

FIG. 4 is a flow chart outlining a process of treating periodontaldisease using the device of FIG. 1, according to an illustrativeembodiment of the present disclosure.

DETAILED DESCRIPTION

The devices, kits and methods described herein will now be describedwith reference to certain illustrative embodiments. However, thedisclosure is not to be limited to these illustrated embodiments whichare provided merely for the purpose of describing the devices, kits andmethods of the disclosure and are not to be understood as limiting inanyway.

FIG. 1 depicts a phototherapeutic device in accordance with presentdisclosure. The phototherapeutic device comprises a flexible fiber optictip member 100 coupled to a light source 300 with an elastic tubularconnector sleeve 200. The flexible fiber optic tip member 100 will bediscussed in greater detail in the descriptions of FIG. 2A-FIG. 2D. Theelastic tubular connector sleeve will be discussed in greater detail inthe descriptions of FIG. 3A and FIG. 3B.

The light source 300 may be any light source commonly found in aclinical setting, including, for example, light sources for photocuring.In some embodiments, the light source 300 comprises an elongated cableof a suitable length to permit a dental professional to work in apatient's mouth. Optionally, the light source 300 provides actiniclight. In some embodiments, the light source 300 comprises lightemitting diodes. Alternatively, the light source 300 may comprise ahalogen lamp. In some embodiments, the light source 300 is configured toprovide light at a wavelength that will activate a photoactivatingagent. By “actinic light” is meant light energy emitted from a specificlight source (e.g., lamp, LED, or laser) and capable of being absorbedby matter (e.g. the photoactivating agent). In a preferred embodiment,the actinic light is visible light. The light source 300 may providevisible light or ultraviolet light. In some embodiments, the lightsource 300 provides visible light having a wavelength between about 400nm and about 800 nm. Furthermore, the light source 300 should have asuitable power density. Suitable power density for non-collimated lightsources (LED, halogen or plasma lamps) are in the range from about 50mW/cm² to about 200 mW/cm², about 30-150 mW/cm², A light beam from thelight source 300 may travel from the light source to the proximal end110 of a flexible fiber optic tip member 100 along the optical axis 190to the distal end 120 for delivery to a periodontal treatment region. Incertain embodiments, the light source 300 may emit a continuous beam oflight or a pulsed beam of light.

The light source 300 may additionally include a control box attached toa flexible fiber optic waveguide to allow a dental professional to placethe free end of the fiber optic waveguide in or near a patient's mouth.The control box of light source 300 may include a lamp, a transformerand a control board, which allows dental professionals to controlvariables such as light intensity and voltage. Light source 300 may becontrolled by a foot pedal, which leaves the dental professionals handsfree to operate the fiber optic waveguide in addition to any otherdental tools. Light source 300 may also include a time-delay, such thatthe light transmitted through the fiber optic wave guide stays on afterthe foot pedal is released.

FIG. 2A depicts a flexible fiber optic tip member 100 in accordance withthe present disclosure. The flexible fiber optic tip member 100 has apolymer core along with a proximal end 110 configured for coupling tothe light source 300 and a distal end 120 configured for insertion intoa periodontal treatment region. The flexible fiber optic tip member 100is configured to have a conical portion 140 proximal to a cylindricalportion 150. The conical portion 140 may have its base at the proximalend 110. The conical portion 140 will be configured to comprise a curvedstructure 130 to focus the light transmitted from the light source 300into the cylindrical portion 150. Further, the flexible fiber optic tipmember 100 is configured such at that light traverses through thepolymer core along the optical axis 190.

FIG. 2B depicts an additional flexible fiber optic tip member 100 inaccordance with the present disclosure. The flexible fiber optic tipmember 100 in FIG. 2B comprises a ridge feature 160, which may beconfigured to be disposed in the distal opening 250 of the elastictubular connecting sleeve to help the flexible fiber optic tip member100 in place near the light source 300. The flexible fiber optic tipmember 100 has a polymer core along with a proximal end 110 configuredfor coupling to the light source 300 and a distal end 120 configured forinsertion into a periodontal treatment region. The flexible fiber optictip member 100 is configured to have a conical portion 140 proximal to acylindrical portion 150. The cylindrical portion 150 can be configuredto comprise a ridge 160 proximal to a flexible portion 170 whichterminates at the distal end 120. The distal end 120 may comprise arounded tip 121. The conical portion 140 may have its base at theproximal end 110. The conical portion 140 will be configured to comprisea curved structure 130 to focus the light transmitted from the lightsource 300 into the cylindrical portion 150. Further, the flexible fiberoptic tip member 100 is configured such at that light traverses throughthe polymer core along the optical axis 190.

FIG. 2C depicts a further flexible fiber optic tip member 100 inaccordance with the present disclosure. The flexible fiber optic tipmember 100 in FIG. 2C comprises a ridge feature 160, which may beconfigured to be disposed in the distal opening 250 of the elastictubular connecting sleeve to help the flexible fiber optic tip member100 in place near the light source 300. Further the flexible fiber optictip member 100 in FIG. 2C comprises a narrowing region 180, along whichthe diameter of the cylindrical portion 150 varies along the length ofthe cylindrical portion 150. The flexible fiber optic tip member 100 hasa polymer core along with a proximal end 110 configured for coupling tothe light source 300 and a distal end 120 configured for insertion intoa periodontal treatment region. The flexible fiber optic tip member 100is configured to have a conical portion 140 proximal to a cylindricalportion 150. The cylindrical portion 150 can be configured to comprise aridge 160 proximal to a flexible portion 170 which terminates at thedistal end 120. The flexible portion 170 may contain a narrowing region180, wherein the diameter of the proximal end of the narrowing region180 is greater than the diameter of the distal end for the narrowingregion 180. The narrowing region 180 may traverse the entire length forthe flexible portion 170, running from the ridge 160 to the distal end120. The conical portion 140 may have its base at the proximal end 110.The conical portion 140 will be configured to comprise a curvedstructure 130 to focus the light transmitted from the light source 300into the cylindrical portion 150. Further, the flexible fiber optic tipmember 100 is configured such at that light traverses through thepolymer core along the optical axis 190.

FIG. 2D depicts another flexible fiber optic tip member 100 inaccordance with the present disclosure. The flexible fiber optic tipmember 100 in FIG. 2D comprises a rough outer surface 123 and a roughtip 122, which allows light traversing through the flexible fiber optictip member 100 to diffuse. The flexible fiber optic tip member 100 has apolymer core along with a proximal end 110 configured for coupling tothe light source 300 and a distal end 120 configured for insertion intoa periodontal treatment region. The flexible fiber optic tip member 100is configured to have a conical portion 140 proximal to a cylindricalportion 150. The cylindrical portion 150 can be configured to comprise aridge 160 proximal to a flexible portion 170 which terminates at thedistal end 120. The distal portion of flexible portion 170 may include arough outer surface 123 configured to allow a portion of lighttransmitted through the flexible portion 170 to diffuse out through therough outer surface 123. Similarly, the distal end 120 may comprise arough tip 122 configured to allow a portion of light transmitted throughthe distal end 120 to diffuse out through the rough tip 122. Theflexible fiber optic tip member 100 may be grated to generate the roughouter surface 123 or the rough tip 122. The conical portion 140 may haveits base at the proximal end 110. The conical portion 140 will beconfigured to comprise a curved structure 130 to focus the lighttransmitted from the light source 300 into the cylindrical portion 150.Further, the flexible fiber optic tip member 100 is configured such atthat light traverses through the polymer core along the optical axis190.

Regarding any of FIG. 2A-2D, the flexible fiber optic tip member 100 maybe unitarily formed. In some embodiments, the flexible fiber optic tipmember is cut from a single block of polymer material. In someembodiments, the polymer core includes polycarbonate. In someembodiments, the flexible fiber optic tip member 100 comprises polymericmaterials such as, for example, any of polycarbonate, polystyrene,polyacrylate and polymethylmethacrylate materials. In some embodiments,the flexible fiber optic tip member 100 comprises glass materials suchas, for example, any of quartz, silica glass, borosilicate glass, leadglass, and fluoride glass materials.

The rough outer surface 123 or rough tip 122 of the flexible fiber optictip member 100 may be generated by any suitable method, includingsandpapering and/or grating the surface of the flexible fiber optic tipmember 100. The rough outer surface 123 or rough tip 122 of the flexiblefiber optic tip member 100 may be generated by sandblasting techniques.

In certain embodiments, flexible fiber optic tip member 100 may beremoved from phototherapeutic periodontal device and disposed of, to bereplaced by a fresh flexible fiber optic tip member 100 in order toavoid cross contamination, for example, between different periodontaldiseased tissue or between patients. The length of the flexible fiberoptic tip member 100 may be between about 10 mm and about 30 mm. Thelength of the flexible fiber optic tip member 100 may be between longerthan about 30 mm, and be trimmed to size by the user.

Still referring to any of FIG. 2A-2D, the curved structure 130 may beconvex relative to the proximal end 110. In other words, the curvedstructure 130 curves toward from the light source 300, which allows theflexible fiber optic tip member 100 to focus light received from thelight source 300 along the optical axis 190 for traversal along thecylindrical portion 150 of the flexible fiber optic tip member 100. Anysuitable degree of curvature may be used as desired so that light isallowed to propagate and focus into the optical fiber. In someembodiments, the diameter of the proximal end 100 of the flexible fiberoptic tip member is the same size as the diameter of the light source300. In some embodiments, the diameter of the proximal end 100 of theflexible fiber optic tip member is the greater than the diameter of thelight source 300, which allows the flexible fiber optic tip member 100to prevent any light from escaping. In certain embodiments, the distancebetween the curved surface 130 and the light source 300 may be selectedsuch that light from the light source 300 is focused into the fiberoptic tip member 100. For example, the curved surface 130 may betouching or in minimal contact or in near proximity to the light source300.

Still referring to any of FIG. 2A-2D, the cylindrical portion 150 of theflexible fiber optic tip member 100 may have a diameter of about0.75-1.0 mm at its proximal end and a diameter of about 0.05-0.2 mm atits distal end 120. In some embodiments, the diameter at the distal end120 of the flexible fiber optic tip member 100 is between about 500micron and about 1500 micron. The cylindrical portion 150 and/or theflexible portion 170 of the flexible fiber optic tip member 100 may besufficiently flexible so as to allow insertion of the distal end 120into small spaces such as periodontal pockets, dental root canals, toothcavities, oral lesions, and other hard to reach sites. The flexiblefiber optic tip member 100 and, in particular, the distal end 120 may beconfigured to deliver and focus light directly to a periodontaltreatment region to provide treatment, and/or to activate aphotoactivating agent in a composition as will be described below. Incertain embodiments, the flexible fiber optic tip member 100 and, inparticular, the distal end 120 may be configured to disperse light inall directions and from both the distal end 120 and/or along a portionof the cylindrical portion 150 or the flexible portion 170 to aid intreatment. In some embodiments, the dispersal light in all directions isachieved by providing a rough end 122 or a rough outer surface 123, asshown in FIG. 2D.

Still referring to any of FIG. 2A-2D, the ridge 160 may be configured tobe partially disposed within the distal opening 250 of the elastictubular connecting sleeve 200. In some embodiments, the diameter of theproximal end of the ridge 160 is greater than the diameter of the distalopening 250 of the elastic tubular connecting sleeve 200. In someembodiments, the diameter of the distal end of the ridge 160 is lessthan the diameter of the distal opening 250 of the elastic tubularconnecting sleeve 200. In some embodiments, the diameter of the ridge160 may be between 5 mm and 10 mm.

FIG. 3A depicts the assembly of a phototherapeutic device in accordancewith the present disclosure. The proximal end 110 of the flexible fiberoptic tip member 100 is coupled to the light source 300. The distal end120 of the flexible fiber optic tip member 100 passes through theelastic tubular connector sleeve 200 and extends beyond the distal end220 of the elastic tubular connector sleeve 200. The proximal end 210 ofthe elastic tubular connector sleeve 200 will extend beyond the proximalend 110 of the flexible fiber optic tip member 100 and will couple tothe light source 300. The elastic tubular connector sleeve 200 will haveone or more flexible ridges 230 which will allow for attachment to thelight source 300 and will firmly hold the flexible fiber optic tipmember 100 in place. When full assembled, the proximal end 110 of theflexible fiber optic tip member 100 will be disposed within the elastictubular connector sleeve 200, such that the proximal end 110 of theflexible fiber optic tip member 100 is between the proximal end 210 andthe distal end 220 of the elastic tubular connector sleeve 200.

FIG. 3B depicts an elastic tubular connector sleeve 200 in accordancewith the present disclosure. The elastic tubular connector sleeve 200comprises a proximal end 210, configured for coupling to a light source300, and a distal end 220, configured to house the cylindrical portion150 of a flexible fiber optic tip member 100. The proximal end 210comprises a proximal opening 240 and the distal end 220 comprises adistal opening 250. A light source 300 will be coupled to the elastictubular connector sleeve through the proximal opening 240. Thecylindrical portion 150 and distal end 120 of a flexible fiber optic tipwill extend through the distal opening 250. The tubular connector sleevecomprises one or more flexible ridges 230 which will allow forattachment to the light source 300 and may help hold the flexible fiberoptic tip member 100 firmly in place.

The proximal end 210 of the elastic tubular connector sleeve 200 isconfigured for coupling to a light source 300, such that the lightsource 300 passes through the proximal opening 240 and is partiallydisposed within the elastic tubular connector sleeve 200. The proximalend 210 may be elastic, such that the diameter of the proximal opening240 can be increased by mechanical stretching. Accordingly, the diameterof the proximal opening 240 may be the same or smaller than the diameterof the light source 300, such that the proximal end 210 must bestretched to dispose the light source 300 in the proximal opening 240.Alternatively, the proximal end 210 may be rigid, such that the diameterof the proximal opening 240 is greater than the diameter of the lightsource 300. In such embodiments, the one or more flexible ridges 230keep the light source 300 partial disposed within the elastic tubularconnector sleeve 200. In some embodiments, the elastic tubular connectorsleeve 200 has multiple layers, including a rigid outer layer and anelastic inner layer that firmly grasps the light source 300.

The distal end 220 of the elastic tubular connector sleeve 200 isconfigured to allow the flexible fiber optic member 100 to extendthrough the distal opening 250. The distal end 220 may be configuredsuch that the cylindrical portion 150 of the flexible fiber optic member100 passes through the distal opening 250. Alternatively, the distal end220 may be configured such that the conical portion 140 of the flexiblefiber optic member 100 passes through the distal opening 250. In furtherembodiments, the distal end 220 may be configured such that the ridge160 of the flexible fiber optic member 100 is partially disposed in thedistal opening 250. In some embodiments, the distal end 220 is elastic,such that the diameter of distal opening 250 may be increased bymechanical stretching. In such embodiments, the diameter of the distalopening 250 may be the same or smaller than the diameter of the conicalportion 140 or the cylindrical portion 150 of the flexible fiber optictip member 100, such that the distal end 220 must be stretched to extendflexible fiber optic tip member 100 through the distal opening 250.Alternatively, the distal end 220 may be rigid, such that the diameterof the distal opening 250 is greater than the diameter of the conicalportion 140 or the cylindrical portion 150 of the flexible fiber optictip member 100. In such embodiments, the one or more flexible ridges 230may keep the flexible fiber optic tip member 100 firmly disposed withinthe elastic tubular connector sleeve 200. Alternatively, the length ofthe elastic tubular connecting sleeve 200 may be short enough that whenthe flexible fiber optic tip member 100 is partial disposed within theconnecting sleeve 200 and the connecting sleeve 200 is coupled to thelight source 300, the flexible fiber optic tip 100 does not have room tomove and is firmly held in place within the connecting sleeve 200. Insome embodiments, the flexible fiber optic tip 100 is contacting thelight source 300. In other embodiments, the flexible fiber optic tip 100is contacting the light source 300, such as less than about 1 mm awayfrom the light source 300.

The one or more flexible ridges 230 may be concentrically disposedwithin the elastic tubular connecting sleeve 200. Alternatively, theflexible ridge 230 may be a single ridge helically disposed within theelastic tubular connecting sleeve 200. The one or more flexible ridges230 may be rigid. In such embodiments, the elastic tubular connectingsleeve 200 may be snapped onto the light source using a lip/clip method.Alternatively, the elastic tubular connecting sleeve 200 may be screwedon to the light source 300 using a threaded system. Alternatively, theone of more flexible ridges 230 may be elastic, such that the proximalend 210 of the elastic tubular connecting sleeve 200 may be mechanicallystretched for coupling to the light source 300.

FIG. 4 depicts a process of treating or preventing periodontal disease400 in accordance with the present disclosure. The process 400 comprisesan attachment 401, wherein a flexible fiber optic tip 100 is attached toa periodontal light source 300 to generate a phototherapeutic device.Preferably, an elastic tubular connecting sleeve 200 is used to attachthe flexible fiber optic tip 100 to the light source 300, as shown inFIG. 1 and FIG. 3A. The process 400 further comprises a compositionintroduction 402, wherein a composition comprising a photoactivatingagent and optionally an oxygen-releasing agent is introduced into aperiodontal treatment region. The process 400 further comprises aflexible tip member introduction 403, wherein the flexible fiber optictip member 100 of the phototherapeutic device is inserted into theperiodontal treatment region. The process 400 further comprises anactivation 404, wherein light from the flexible fiber optic tip member100 activates the photoactivating agent.

In one example, upon activation with light from the flexible fiber optictip 100, the photoactivating agent absorbs energy from the light andreleases some of the absorbed light energy as a fluorescent light.Without being bound to theory, it is thought that fluorescent lightemitted by photoactivated chromophores may have therapeutic propertiesdue to its femto-second or pico-second emission properties which may berecognized by biological cells and tissues, leading to favourablebiomodulation. Furthermore, the emitted fluorescent light has a longerwavelength and hence a deeper penetration into the tissue than theactivating light. Irradiating tissue with such a broad range ofwavelength, including in some embodiments the activating light whichpasses through the composition, may have different and complementarytherapeutic effects on the cells and tissues.

In another example, the composition also comprises an oxygen-releasingagent. In this case, the photoactivating agent may transfer at leastsome of the absorbed light energy to the oxygen-releasing agent, whichin turn can produce oxygen radicals such as singlet oxygen. These aredistinct applications of these agents and differs from the use ofchromophores as simple stains or as a catalyst for photo-polymerization.

Suitable photoactivating agents include fluorescent dyes (or stains),biological dyes, histological dyes, food colorings, naturally occurringphotoactive agents and carotenoids.

Suitable photoactivating agents include, but are not limited to, thefollowing:

Chlorophyll Dyes

Exemplary chlorophyll dyes include but are not limited to chlorophyll a;chlorophyll b; oil soluble chlorophyll; bacteriochlorophyll a;bacteriochlorophyll b; bacteriochlorophyll c; bacteriochlorophyll d;protochlorophyll; protochlorophyll a; amphiphilic chlorophyll derivative1; amphiphilic chlorophyll derivative 2, phycobiliproteins.

Xanthene Derivatives

Exemplary xanthene dyes include but are not limited to Eosin B(4′,5′-dibromo,2′,7′-dinitr-o-fluorescein, dianion); eosin Y; eosin Y(2′,4′,5′,7′-tetrabromo-fluoresc-ein, dianion); eosin(2′,4′,5′,7′-tetrabromo-fluorescein, dianion); eosin(2′,4′,5′,7′-tetrabromo-fluorescein, dianion) methyl ester; eosin(2′,4′,5′,7′-tetrabromo-fluorescein, monoanion) p-isopropylbenzyl ester;eosin derivative (2′,7′-dibromo-fluorescein, dianion); eosin derivative(4′,5′-dibromo-fluorescein, dianion); eosin derivative(2′,7′-dichloro-fluorescein, dianion); eosin derivative(4′,5′-dichloro-fluorescein, dianion); eosin derivative(2′,7′-diiodo-fluorescein, dianion); eosin derivative(4′,5′-diiodo-fluorescein, dianion); eosin derivative(tribromo-fluorescein, dianion); eosin derivative(2′,4′,5′,7′-tetrachlor-o-fluorescein, dianion); eosin; eosindicetylpyridinium chloride ion pair; erythrosin B(2′,4′,5′,7′-tetraiodo-fluorescein, dianion); erythrosin; erythrosindianion; erythiosin B; fluorescein; fluorescein dianion; phloxin B(2′,4′,5′,7′-tetrabromo-3,4,5,6-tetrachloro-fluorescein, dianion);phloxin B (tetrachloro-tetrabromo-fluorescein); phloxine B; rose bengal(3,4,5,6-tetrachloro-2′,4′,5′,7′-tetraiodofluorescein, dianion); pyroninG, pyronin J, pyronin Y; Rhodamine dyes such as rhodamines include4,5-dibromo-rhodamine methyl ester; 4,5-dibromo-rhodamine n-butyl ester;rhodamine 101 methyl ester; rhodamine 123; rhodamine 6G; rhodamine 6Ghexyl ester; tetrabromo-rhodamine 123; and tetramethyl-rhodamine ethylester.

Methylene Blue Dyes

Exemplary methylene blue derivatives include but are not limited to1-methyl methylene blue; 1,9-dimethyl methylene blue; methylene blue;methylene blue (16 .mu.M); methylene blue (14 .mu.M); methylene violet;bromomethylene violet; 4-iodomethylene violet;1,9-dimethyl-3-dimethyl-amino-7-diethyl-a-mino-phenothiazine; and1,9-dimethyl-3-diethylamino-7-dibutyl-amino-phenot-hiazine.

Azo Dyes

Exemplary azo (or diazo-) dyes include but are not limited to methylviolet, neutral red, para red (pigment red 1), amaranth (Azorubine S),Carmoisine (azorubine, food red 3, acid red 14), allura red AC (FD&C40), tartrazine (FD&C Yellow 5), orange G (acid orange 10), Ponceau 4R(food red 7), methyl red (acid red 2), and murexide-ammonium purpurate.

In some aspects of the disclosure, the one or more photoactivatingagents of the biophotonic composition disclosed herein can beindependently selected from any of Acid black 1, Acid blue 22, Acid blue93, Acid fuchsin, Acid green, Acid green 1, Acid green 5, Acid magenta,Acid orange 10, Acid red 26, Acid red 29, Acid red 44, Acid red 51, Acidred 66, Acid red 87, Acid red 91, Acid red 92, Acid red 94, Acid red101, Acid red 103, Acid roseine, Acid rubin, Acid violet 19, Acid yellow1, Acid yellow 9, Acid yellow 23, Acid yellow 24, Acid yellow 36, Acidyellow 73, Acid yellow S, Acridine orange, Acriflavine, Alcian blue,Alcian yellow, Alcohol soluble eosin, Allophycocyanin (APC), Alizarin,Alizarin blue 2RC, Alizarin carmine, Alizarin cyanin BBS, Alizarolcyanin R, Alizarin red S, Alizarin purpurin, Aluminon, Amido black 10B,Amidoschwarz, Aniline blue WS, Anthracene blue SWR, Auramine O,Azocannine B, Azocarmine G, Azoic diazo 5, Azoic diazo 48, Azure A,Azure B, Azure C, Basic blue 8, Basic blue 9, Basic blue 12, Basic blue15, Basic blue 17, Basic blue 20, Basic blue 26, Basic brown 1, Basicfuchsin, Basic green 4, Basic orange 14, Basic red 2, Basic red 5, Basicred 9, Basic violet 2, Basic violet 3, Basic violet 4, Basic violet 10,Basic violet 14, Basic yellow 1, Basic yellow 2, Biebrich scarlet,Bismarck brown Y, Brilliant crystal scarlet 6R, Calcium red, Carmine,Carminic acid, Celestine blue B, China blue, Cochineal, Coelestine blue,Chrome violet CG, Chromotrope 2R, Chromoxane cyanin R, Congo corinth,Congo red, Cotton blue, Cotton red, Croceine scarlet, Crocin, Crystalponceau 6R, Crystal violet, Dahlia, Diamond green B, Direct blue 14,Direct blue 58, Direct red, Direct red 10, Direct red 28, Direct red 80,Direct yellow 7, Eosin B, Eosin Bluish, Eosin, Eosin Y, Eosin yellowish,Eosinol, Erie garnet B, Eriochrome cyanin R, Erythrosin B, Ethyl eosin,Ethyl green, Ethyl violet, Evans blue, Fast blue B, Fast green FCF, Fastred B, Fast yellow, Fluorescein, Food green 3, Gallein, Gallamine blue,Gallocyanin, Gentian violet, Haematein, Haematine, Haematoxylin, Heliofast rubin BBL, Helvetia blue, Hematein, Hematine, Hematoxylin,Hoffman's violet, Indocyanin green, Imperial red, Ingrain blue, Ingrainblue 1, Ingrain yellow 1, INT, Kermes, Kermesic acid, Kernechtrot, Lac,Laccaic acid, Lauth's violet, Light green, Lissamine green SF, Luxolfast blue, Magenta 0, Magenta I, Magenta II, Magenta III, Malachitegreen, Manchester brown, Martius yellow, Merbromin, Mercurochrome,Metanil yellow, Methylene azure A, Methylene azure B, Methylene azure C,Methylene blue, Methyl blue, Methyl green, Methyl violet, Methyl violet2B, Methyl violet 10B, Mordant blue 3, Mordant blue 10, Mordant blue 14,Mordant blue 23, Mordant blue 32, Mordant blue 45, Mordant red 3,Mordant red 11, Mordant violet 25, Mordant violet 39 Naphthol blueblack, Naphthol green B, Naphthol yellow S, Natural black 1, Naturalred, Natural red 3, Natural red 4, Natural red 8, Natural red 16,Natural red 25, Natural red 28, Natural yellow 6, NBT, Neutral red, Newfuchsin, Niagara blue 3B, Night blue, Nile blue, Nile blue A, Nile blueoxazone, Nile blue sulphate, Nile red, Nitro BT, Nitro blue tetrazolium,Nuclear fast red, Oil red O, Orange G, Orcein, Pararosanilin, PhloxineB, Phycocyanins, Phycoerythrins. Phycoerythrincyanin (PEC),Phthalocyanines, Picric acid, Ponceau 2R, Ponceau 6R, Ponceau B, Ponceaude Xylidine, Ponceau S, Primula, Purpurin, Pyronin B, Pyronin G, PyroninY, Rhodamine B, Rosanilin, Rose bengal, Saffron, Safranin O, Scarlet R,Scarlet red, Scharlach R, Shellac, Sirius red F3B, Solochrome cyanin R,Soluble blue, Solvent black 3, Solvent blue 38, Solvent red 23, Solventred 24, Solvent red 27, Solvent red 45, Solvent yellow 94, Spiritsoluble eosin, Sudan III, Sudan IV, Sudan black B, Sulfur yellow S,Swiss blue, Tartrazine, Thioflavine S, Thioflavine T, Thionin, Toluidineblue, Toluyline red, Tropaeolin G, Trypaflavine, Trypan blue, Uranin,Victoria blue 4R, Victoria blue B, Victoria green B, Water blue I, Watersoluble eosin, Xylidine ponceau, or Yellowish eosin.

In certain embodiments, the composition of the present disclosureincludes any of the chromophores listed above, or a combination thereof,so as to provide a biophotonic impact at the application site.Photoactive agent compositions may increase photo-absorption by thecombined dye molecules or may enhance photo-biomodulation selectivity.In some embodiments, the combination of photoactive agents may besynergistic. In some embodiments, the two or more photoactive agents areboth xanthene dyes, for example, Eosin Y as a first chromophore and anyone or more of Rose Bengal, Erythrosin, Phloxine B as a secondchromophore. It is believed that these combinations have a synergisticeffect as Eosin Y can transfer energy to Rose Bengal, Erythrosin orPhloxine B when activated. This transferred energy is then emitted asfluorescence or by production of reactive oxygen species. By means ofsynergistic effects of the chromophore combinations in the composition,chromophores which cannot normally be activated by an activating light(such as a blue light from an LED) can be activated through energytransfer from chromophores which are activated by the activating light.In this way, the different properties of photoactivated chromophores canbe harnessed and tailored according to the cosmetic or the medicaltherapy required.

As discussed above, the photoactivating agent stimulates theoxygen-releasing agent in the composition to produce oxygen radicals.Bacteria are extremely sensitive to exposure to oxygen radicals, suchthat the production of oxygen radicals converts the composition into abactericidal composition. Peroxide compounds are oxygen-releasing agentsthat contain the peroxy group (R—O—O—R), which is a chainlike structurecontaining two oxygen atoms, each of which is bonded to the other and aradical or some element. When a biophotonic composition of the presentdisclosure comprising an oxygen-releasing agent is illuminated withlight, the chromophores are excited to a higher energy state. When thechromophores' electrons return to a lower energy state, they emitphotons with a lower energy level, thus causing the emission of light ofa longer wavelength (Stokes' shift). In the proper environment, some ofthis energy transfer is transferred to oxygen or the reactive hydrogenperoxide and causes the formation of oxygen radicals, such as singletoxygen. The singlet oxygen and other reactive oxygen species generatedby the activation of the biophotonic composition are thought to operatein a hormetic fashion. That is, a health beneficial effect that isbrought about by the low exposure to a normally toxic stimuli (e.g.reactive oxygen), by stimulating and modulating stress response pathwaysin cells of the targeted tissues. Endogenous response to exogenousgenerated free radicals (reactive oxygen species) is modulated inincreased defense capacity against the exogenous free radicals andinduces acceleration of healing and regenerative processes. Furthermore,activation of the composition will also produce an antibacterial effect.The extreme sensitivity of bacteria to exposure to free radicals makesthe composition of the present disclosure a de facto bactericidalcomposition.

Suitable oxygen-releasing agents for preparation of the active mediuminclude, but are not limited to:

Hydrogen peroxide (H₂O₂) is the starting material to prepare organicperoxides. H₂O₂ is a powerful oxidizing agent, and the unique propertyof hydrogen peroxide is that it breaks down into water and oxygen anddoes not form any persistent, toxic residual compound. Hydrogen peroxidefor use in this composition can be used in a gel, for example with 6%hydrogen peroxide. A suitable range of concentration over which hydrogenperoxide can be used in the present composition is from about 0.1% toabout 6%.

Urea hydrogen peroxide (also known as urea peroxide, carbamide peroxideor percarbamide) is soluble in water and contains approximately 35%hydrogen peroxide. Carbamide peroxide for use in this composition can beused as a gel, for example with 16% carbamide peroxide that represents5.6% hydrogen peroxide. A suitable range of concentration over whichurea peroxide can be used in the present composition is from about 0.3%to about 16%. Urea peroxide brakes down to urea and hydrogen peroxide ina slow-release fashion that can be accelerated with heat orphotochemical reactions. The released urea [carbamide, (NH₂)CO₂)], ishighly soluble in water and is a powerful protein denaturant. Itincreases solubility of some proteins and enhances rehydration of theskin and/or mucosa.

Benzoyl peroxide consists of two benzoyl groups (benzoic acid with the Hof the carboxylic acid removed) joined by a peroxide group. It is foundin treatments for acne, in concentrations varying from 2.5% to 10%. Thereleased peroxide groups are effective at killing bacteria. Benzoylperoxide also promotes skin turnover and clearing of pores, whichfurther contributes to decreasing bacterial counts and reduce acne.Benzoyl peroxide breaks down to benzoic acid and oxygen upon contactwith skin, neither of which is toxic. A suitable range of concentrationover which benzoyl peroxide can be used in the present composition isfrom about 2.5% to about 5%.

Specific oxygen-releasing agents that that are preferably used in thematerials or methods of this disclosure include, but are not limited tohydrogen peroxide, carbamide peroxide, or benzoyl peroxide. Inclusion ofother forms of peroxides (e.g. organic or inorganic peroxides) should beavoided due to their increased toxicity and their unpredictable reactionwith the photodynamic energy transfer.

In certain embodiments, the photoactivating agent may be incorporated inthe matrix of the flexible fiber optic tip. In this way, the flexiblefiber optic tip can be made to fluoresce on activation with a light. Anoxygen-releasing agent may also be included within the matrix of theflexible fiber optic tip. The concentration of the photoactive agent tobe used can be selected based on the desired intensity and duration ofthe biophotonic activity from the flexible fiber optic tip. For example,some dyes such as xanthene dyes (e.g. Eosin Y and Fluorescein) reach a‘saturation concentration’ after which further increases inconcentration do not provide substantially higher emitted fluorescence.Further increasing the photoactive agent concentration above thesaturation concentration can reduce the amount of activating lightpassing through the solid biophotonic. Therefore, if more fluorescenceis required for a certain application than activating light, a high‘saturation’ concentration of the photoactive agent can be used.However, if a balance is required between the emitted fluorescence andthe activating light, a concentration close to or lower than thesaturation concentration can be chosen.

What is claimed is:
 1. A method for phototherapy, comprising: attachingto a light source a probe member, the probe member having: a flexiblefiber optic tip member with a polymer or glass core for transmittinglight to a photoactivating agent, wherein the photoactivating agent is:i) within the polymer or glass core; ii) on a surface of the polymer orglass core; and/or iii) on a surface of a treatment site, the flexiblefiber optic tip member including a proximal end and a distal end,wherein the proximal end of the flexible fiber optic tip member iscurved to cause light entering the flexible fiber optic tip memberthrough the proximal end of the flexible fiber optic tip member toconverge, and an elastic tubular connector sleeve, for mechanicallycoupling the flexible tip member to a light source, wherein the elastictubular connector sleeve includes a proximal end having an opening and adistal end having an opening, the proximal end of the elastic tubularconnector sleeve configured to be stretched and mechanically coupled tothe light source, wherein the flexible fiber optic tip member ispartially disposed within the sleeve, in use, such that the distal endof the flexible fiber optic tip member extends distally through theopening in the distal end of the sleeve, and the proximal end of theflexible fiber optic tip member is disposed within the sleeve andbetween the proximal and distal ends of the sleeve, thereby positioningthe flexible fiber optic tip member near the light source; introducingthe flexible tip member in a treatment region; and activating thephotoactivating agent by applying light through the flexible fiber optictip member.
 2. A method as defined in claim 1, wherein the diameter ofthe proximal end of the flexible fiber optic tip member is greater thanthe diameter of the distal end of the flexible fiber optic tip member.3. A method as defined in claim 1, wherein the flexible fiber optic tipmember is unitarily formed.
 4. A method as defined in claim 1, whereinthe flexible fiber optic tip member comprises a plurality of bristles atthe distal end.
 5. A method as defined in claim 1, wherein the polymercore comprises polycarbonate or polymethylmethacrylate.
 6. A method asdefined in claim 1, wherein the flexible fiber optic tip member includesan optical axis extending through the center of the polymer core fromthe proximal end to the distal end, and wherein light passing throughthe flexible fiber optic tip member travels along at least a portion ofthe optical axis.
 7. A method as defined in claim 1, wherein a lengthfrom the proximal end to a distal end of the flexible fiber optic tipmember is between 10 mm and 30 mm.
 8. A method as defined in claim 1,wherein a diameter at the distal end of the flexible fiber optic tipmember is between 500 microns and 1500 microns.
 9. A method as definedin claim 1, wherein the light source includes one or more light emittingdiodes or a halogen lamp.
 10. A method as defined in claim 1, whereinthe light is visible light having a wavelength between 400 nm and 800nm.
 11. A method as defined in claim 1, wherein the treatment region isexposed to light for a period of less than 5 minutes.
 12. A method asdefined in claim 1, wherein the treatment region is exposed to light fora period of 60 seconds to 5 minutes.
 13. A method as defined in claim 1,wherein the treatment region is a wound.
 14. A method as defined inclaim 1, wherein the treatment region is an internal tissue.
 15. Amethod as defined in claim 1, wherein the photoactivating agent is oneor more of a xanthene derivative dye, an azo dye, a biological stain ora carotenoid.
 16. A method as defined in claim 15, wherein the xanthenederivative dye is a fluorene dye, a fluorone dye or a rhodole dye.
 17. Amethod as defined in claim 1, wherein the photoactivating agent is oneor more of a fluorescein and a fluorescein derivative.
 18. A method asdefined in claim 17, wherein the one or more of a fluorescein and afluorescein derivative is Phloxine B, Rose Bengal, Merbromine, Eosin Y,Eosin B or Erythrosine B.
 19. A method as defined in claim 1, whereinthe probe member further comprises one or more oxygen releasing agentwithin the polymer or glass core or on a surface of the polymer or glasscore.
 20. A method as defined in claim 19, wherein the one or moreoxygen releasing agent is alkali metal peroxides, alkali metalpercarbonates, alkali metal perborates or any combinations thereof. 21.A method for phototherapeutic treatment of a wound, the methodcomprising: attaching to a light source a probe member, the probe memberhaving a flexible fiber optic tip member with a polymer or glass corefor transmitting light to a photoactivating agent, wherein thephotoactivating agent is: i) within the polymer or glass core; ii) on asurface of the polymer or glass core; and/or iii) on a surface of atreatment site, the flexible fiber optic tip member including a proximalend and a distal end wherein the proximal end of the flexible fiber tipmember is curved to cause light entering the flexible fiber optic tipmember through the proximal end of the flexible fiber optic tip memberto converge; and an elastic tubular connector sleeve, for mechanicallycoupling the flexible tip member to a light source, wherein the elastictubular connector sleeve includes a proximal end having an opening and adistal end having an opening, the proximal end of the elastic tubularconnector sleeve configured to be stretched and mechanically coupled tothe light source; wherein the flexible fiber optic tip member ispartially disposed within the sleeve, in use, such that the distal endof the flexible fiber optic tip member extends distally through theopening in the distal end of the sleeve, and the proximal end of theflexible fiber optic tip member is disposed within the sleeve andbetween the proximal and distal ends of the sleeve, thereby positioningthe flexible fiber optic tip member near the light source; introducingthe flexible tip member into the wound; and activating thephotoactivating agent by applying light through the flexible fiber optictip member.